Implantable medical device which may be controlled from central station

ABSTRACT

An implantable medical device (IMD) comprises a transmitting/receiving (T/R) device for transmitting medical data sensed from a patient to, and for receiving control signals from, a medical expert (a human medical professional and/or a computerized expert system) at a remote location; an electronic medical treatment device for treating the patient in response to control signals applied thereto; and a sensor circuit, having a sensor circuit output, for producing sensor circuit output signal(s) representing medical data sensed from the patient. The IMD also includes a logic device (processor) which analyzes the sensor circuit output signal(s) to detect a medical abnormality and, upon detecting an abnormality, either sends a notification signal representing a medical state of said patient to the medical expert at the remote location or sends a local treatment device control signal to the medical treatment device, or does both. The medical expert can transmit an external treatment control signal to the IMD to effect patient treatment, if treatment is warranted. To ensure that the medical expert is authorized to provide such treatment, data which identify one or more authorized medical experts is stored in an IMD memory and compared with identification data transmitted from the putative authorized medical expert along with the external treatment control signal. Only if the identification data received from the putative authorized medical expert matches the pre-stored identification data of an originally authorized medical expert does the IMD effect treatment.

CROSS-REFERENCE TO RELATED PATENTS AND PATENT APPLICATIONS

This application is a continuation-in-part of, and claims priority from,U.S. patent application Ser. No. 14/076,521, filed Nov. 11, 2013, whichwill issue on Aug. 12, 2014 as U.S. Pat. No. 8,805,529 and which, inturn, was a continuation of the U.S. patent application Ser. No.13/795,250 filed Mar. 12, 2013 and which issued on Nov. 12, 2013, asU.S. Pat. No. 8,583,251. This grandparent application, in turn, was acontinuation of, and claimed priority from, the U.S. patent applicationSer. No. 12/154,079, filed May 19, 2008, which issued on Jun. 25, 2013as U.S. Pat. No. 8,214,043 and which, in turn, claimed priority from theProvisional Application No. 60/930,525 filed May 17, 2007.

The subject matter of this application is also related to that of U.S.Pat. Nos. 7,277,752; 8,214,043; 8,233,672; 8,565,882; 8,655,450 and8,706,225; and U.S. patent application Ser. No. 11/502,484, filed Aug.10, 2006; U.S. patent application Ser. No. 12/714,649, filed Mar. 1,2010; U.S. patent application Ser. No. 13/563,399, filed Jul. 31, 2012(U.S. Patent Pub. No. 2012/0314048); U.S. patent application Ser. No.13/834,634, filed Mar. 15, 2013; and U.S. patent application Ser. No.14/258,604 filed Apr. 22, 2014; all of which patents and patentapplications are incorporated herein by reference.

BACKGROUND OF THE INVENTION

An early generation of implantable cardioverter-defibrillators, “ICDs”had one programmable function: on and off. The modern version of thedevice has dozens of programmable parameters. In fact, it is now notuncommon for physicians who regularly use such devices to not be fullyversed in all of the possible programming complexities of the devicesthat they implant. Furthermore, the optimal value of some programmableparameters cannot be known at the time of device implantation.Physicians will not uncommonly guess at the values to be programmed foranti-tachycardia pacing, because they may not be able to accuratelyreproduce the tachycardia that a patient may later have. It is thereforenot uncommon for physicians to reprogram such parameters, weeks, monthsor years later, after the occurrence of the actual event showed thatthey had not guessed well. Occasionally, the examples are striking Apatient, for example with an ICD and both ventricular tachycardia andatrial fibrillation may get not just one but quite a few inappropriatedefibrillator shocks, because of an inappropriately selected programmedrate cutoff, stability parameter, etc. The opposite sort of phenomenonmay also occur. For example, a patient with known ventriculartachycardia, “VT”, at 200 beats per minute, “bpm”, may have the VTdetect rate of an ICD programmed to 180, and may later collapse becauseof an unexpected episode of VT below the rate cutoff.

Occasionally, the malfunctioning of an implanted device can have veryserious consequences. The Ventritex V-110 defibrillator at one point hada failure mode which resulted in the sudden death of at least onepatient. The “fix” for it, was a programming fix, wherein thedownloading of certain instructions prevented the device from beingsubject to this malfunction.

The explosive growth of modern communication systems allows for thepossibility of remote supervision and management of implantable devices,and addressing of the aforementioned problems. An ICD which may beproviding numerous inappropriate shocks over a short time period—eitherdue to device malfunction, lead malfunction or inappropriate programmingof a properly functioning system, could be remotely identified andreprogrammed, for example.

A variety of other devices which perform critical functions which remotecontrol could enhance. These include cardiac pumps, insulin pumps, brainstimulating devices and others.

There are certain requirements that must be fulfilled if some of theautonomy of device function is to be impinged on. Remote control over afaulty communication link could create problems instead of solving them,so reliability of communications, careful communication monitoring,redundancy and contingency planning, are all features of a remotelycontrollable implantable device. Since the communication process usesbattery power, judicious power management is also a necessity.

Since the gaining of access to IMD control by an inappropriate ornon-authorized person may have major or dire consequences, it is ofvalue to prevent system access by any such inappropriate person.

One approach to the problem is simply to require an alphanumeric useridentification. Such an approach has the obvious limitation of easilybreached device security, upon loss, theft, or other unintendedacquisition of the device access information.

A more secure approach is requiring the user to input a “biologicidentifier”—e.g. a fingerprint, an iris pattern, retinal blood vesselpattern, palm or finger blood vessel pattern, facial image, voice orvoice print, etc. These too can be “hacked”, since it is possible toobtain such biologic identification without the agreement of the personwhose identification is purloined.

A still more secure approach, presented herein relies on more securesystems of user identification.

SUMMARY OF THE INVENTION

Hereinbelow: Medical Expert, “ME”, refers to either a person (a “medicalprofessional”) or an expert computational system. The word “user” refersto a person (or entity) wishing to gain access to the control of aremotely controllable device.

The inventions disclosed herein concern methods and apparatus forremotely controlling implantable medical devices such as ICDs,pacemakers, drug infusion pumps, brain stimulators etc. In order toconserve battery power, the communication link between the device and amedical expert is designed to function only when needed. Such need isdefined by preprogramming certain notification criteria, such that thedevice initiates communication with a ME only when the assistance ofthat ME may be needed. Following notification the ME may observe thesensor information that the device observes in making a devicemanagement decision. Furthermore, the ME may have access to additionalinformation e.g. historical information within the device memory,historical information about the particular patient from one or moreaccessible databases, and information about a plurality of patients withthe device from still other databases. The ME may have a variety ofcontrol-sharing relationships with the implanted device ranging fromcomplete control (with simultaneous complete inhibition of internalcontrol circuits), or a sharing arrangement in which, for example, boththe ME and the control circuits of the IMD may be able to influencetreatment. Following such an encounter, the ME may modify the devicefunctioning by reprogramming a number of parameters (e.g. notificationparameters, a value of one or more parameters which define a thresholdfor treatment, the actual treatment parameters, battery management, andthe nature of the control-sharing arrangement for future episodesinvolving notification).

To provide security against unauthorized persons gaining access to thecontrol of the IMD, a number of inventive approaches are presentedherein.

In a first preferred embodiment, user identification is performed duringthe inputting of a control signal to control an IMD.

In a second preferred embodiment, the system of the first embodiment isenhanced by remotely manipulating user biologic features (e.g. theremote control of a light source which causes light to impinge on theuser's eye, which in turn causes a change in the size of the user's irisand pupil).

The IMD may be any implantable medical device, including but not limitedto: a pacemaker, a defibrillator, an infusion pump, a closed loopdiabetes control device, a brain stimulator, a nerve stimulator, amuscle stimulator, a gastric stimulator, a carotid sinus stimulator, aleft or right ventricular assist device, a totally implanted heart, abladder control device, a pain management device and other such devicesas are known in the art.

The devices discussed herein are implanted, but the application of thistechnology to external medical devices parallels that of the implantedversions.

Furthermore, the user ID approach described herein is applicable tousers of all electronic systems in which security is desirable includingmedical record systems, data banks, credit card and other electronicallyinteractive remote business transactions, security buying, trading andselling, legal contract execution, voting systems, public governmentmanagement systems, corporate and small business management systems,remote aircraft control, remote control of ground, water and space-basedvehicles, personal communications, cloud based data management, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a representational block diagram of an implantable medicaldevice (“IMD”) which may be remotely controlled.

FIG. 2A is a representational block diagram of a system including anIMD, a sensor and a remote station to be operated by a human medicalexpert.

FIG. 2B is a representational block diagram of a system including anIMD, a sensor and a remote station operated by a medical expertcomputational device.

FIG. 2C is a representational block diagram of a system including anIMD, a sensor and a remote station operated by a computational deviceand a further remote station operated by a human medical expert.

FIG. 3A is a flow diagram of a communication routine for a remotelycontrollable IMD.

FIG. 3B is a flow diagram of a communication routine for a remotestation which communicates with a remotely controllable IMD.

FIG. 4A is a representational block diagram showing remotely controlledpower management for a remotely controllable IMD with one battery.

FIG. 4B is a representational block diagram showing locally controlledpower management for a remotely controllable IMD with one battery.

FIG. 4C is a representational block diagram showing remotely controlledpower management for a remotely controllable IMD with two batteries.

FIG. 4D is a representational block diagram showing locally controlledpower management for a remotely controllable IMD with two batteries.

FIGS. 5A and 5B each show a graphic representation of some possiblearithmetic relationships illustrating the notification definition andthe parameter abnormality definition.

FIG. 6A shows a flow diagram of one possible algorithm for notification.

FIG. 6B shows another flow diagram of one possible algorithm fornotification.

FIG. 6C shows another flow diagram of one possible algorithm fornotification.

FIG. 6D shows another flow diagram of one possible algorithm fornotification.

FIG. 7 shows a representational block diagram of a communications relayand its links to an IMD and a remote station

FIG. 8 show an overview of one approach to ICD management.

FIG. 9 shows a representational diagram of communication with multiplerelays.

FIG. 10 shows a representational diagram of ICD communication via apersonal communication device.

FIG. 11 shows a flow diagram of an ICD management algorithm allowingremote notification and management.

FIG. 12 shows a representational block diagram of a remotely andinternally controllable IMD which determines the identification of aperson wishing to remotely control the IMD.

FIG. 13 shows a representational block diagram of a system with aremotely and internally controllable IMD which determines theidentification of a person wishing to remotely control the IMD, and aremote control device with a single input for inputting both useridentification and user device control information.

FIG. 14 shows a representational block diagram of a system with aremotely and internally controllable IMD which determines theidentification of a person wishing to remotely control the IMD, and aremote control device with a single input for inputting both useridentification and user device control information, and with apresentation device for displaying information for the user.

FIG. 15 shows a representational block diagram of a system with aremotely and internally controllable IMD which determines theidentification of a person wishing to remotely control the IMD, and aremote control device with two inputs: one for inputting identificationinformation and another one for inputting device control information.

FIG. 16 shows a representational block diagram of a system with aremotely and internally controllable IMD which determines theidentification of a person wishing to remotely control the IMD; and aremote control device with two inputs: a camera and a second inputdevice.

FIG. 17 is a representational block diagram of the system of FIG. 13,with a camera providing both control and identification information.

FIG. 18 is a representational block diagram of the dual control IMDsystem with both camera and keypad inputs.

FIG. 19 is a representational diagram of memory file notation andallocation in the dual control IMD system.

FIG. 20 is another representational diagram of memory file notation andallocation in the dual control IMD system.

FIG. 21 is a representational diagram illustrating the dual acquisitionof biologic identification information and control information.

FIG. 22 is a representation block diagram of an automatically operatingremote control station for the dual control IMD, with identification ofthe remote control station.

FIG. 23 is a representational block diagram of the use of prompts toidentify a device user.

FIG. 24 is a representational diagram of the response of a human iris tolight and to other prompts.

FIG. 25 is a representational block diagram of the user identified, dualcontrol IMD with a light source supplying prompts, a camera and anotherinput device.

FIG. 26 is a representational block diagram of the user identified, dualcontrol IMD with a text source supplying prompts, a camera and anotherinput device.

FIG. 27 is a representational block diagram of the user identified, dualcontrol IMD with a sound source supplying prompts, a camera and anotherinput device.

FIG. 28 is a representational block diagram of the user identified, dualcontrol IMD with a pain source supplying prompts, a camera and anotherinput device.

FIG. 29 is a representational block diagram of the user identified, dualcontrol IMD with a prompt producing device, a microphone and anotherinput device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows an implantable medical device 10 which has the capacity tonotify a remotely located medical expert. Sensor circuit 12, with output14, outputs sensor circuit output signals 15. The signals contain dataregarding the measurement of at least one medical parameter, a parameterwhich allows the logic device 16 of the IMD to make treatment decisions.15 may be an analog signal or a digitized one, as is known in the art.Means for amplification, of 15 and other techniques for signalmanagement as are known in the art, may reside within 12. The sensorcircuit is coupled to a sensor, as discussed hereinbelow.

Logic device 16 analyzes signals 15 to determine if there is a need for(a) treatment of a medical abnormality, and/or (b) notification of aremotely located medical expert. Scenarios are possible in which:

1) the abnormality which calls for notification is the same as thatwhich call for treatment;2) the abnormality which calls for notification is less severe than thatwhich requires treatment;3) the abnormality which calls for notification is more severe than thatwhich requires treatment; and4) the abnormality which calls for notification is different than thatwhich requires treatment.

By way of example: In the case of 2) and 4) hereinabove, there may beabnormalities which, though not severe enough to always requiretreatment, might require treatment under certain circumstances which areapparent to an expert person or system. Thus, providing an ICD shock forVT with a rate of over 240 bpm would be likely to represent soundmanagement much of the time, but the desirability of providing an ICDshock for VT at 140 bpm will depend on a variety of circumstances. Someof these may be easily programmed, such as the duration of the event VT.But others may not. If the ICD in the example was connected to multiplesensors, then a complex decision based on the patient's blood pressure,respiratory rate, and even recent medical history and/or response toantitachycardia pacing in the past might all be factors that would beadvisably considered in making a shock/no shock decision. In the case oftherapy decision making based on multiple sensors, it becomes impossibleto simply say that on set of abnormalities is more severe than another,and “different” is the appropriate term. Thus a VT rate of 140 and ablood pressure of 80 systolic may or may not be considered more severethan a situation with VT at 240 and a blood pressure of 90. Clearly, asthe number of different types of sensors increases, and treatmentdecisions must be based on the data from each of them, algorithms willbe more difficult to design, and there will be decreasing likelihoodthat such algorithms can match the decision making ability of a medicalexpert, “ME” (person or computational system). The value of having thedevice “seek consultation” with a ME under these circumstances is clear.At times, the blending of information from multiple sensors may be bestaccomplished using mathematical techniques which are beyond the scope ofa routinely implanted device. Ultimately, treatment decisions may bebased on complex functions of multiple parameters and time. Note is madeof the fact that these functions may not meet all of the formalmathematical criteria of a function, since input data may not becontinuous in nature.

By way of yet another example: It may be desirable to notify and ME onlyin cases of extreme abnormality, and to omit such notification forroutine treatments. In such a circumstance, 16 could be operative totreat non-severe abnormalities without notification and to notify a MEfor very severe ones. It could be further operative to treat the severeones unless, having been notified of a severe event, a ME chooses tooverride the decision of a MP. Thus a single episode of VT at 240 beatsper minute might be treated with a shock without notification of an ME,but four episodes of the same VT over 15 minutes might warrantnotification.

Device 16 may be a microprocessor, a group of microprocessors or othercomputational devices as is known in the art. When preset criteria forME notification have been met, it signals a ME by sending notificationsignal 18 to first transmitting/receiving device. “first T/R” 20, whichis transmitted to the ME. 20 may consist of a single unit which performsboth transmitting and receiving functions, or separate units. Thetransmission methods are discussed hereinbelow. Along with thenotification signal, the logic device will send medical data 32 for theME to evaluate. The data may include (a) actual signals 15, (b) aprocessed form of 15, e.g. filtered, compressed, etc., (c) a furtherrefined form of 15 [e.g. beat to beat measurements of cardiac RRintervals], and (d) still further refined forms of data [e.g. theinformation that 17 of the last 20 beats were at a rate greater than200].

The ME has a variety of options upon receipt of this information,discussed hereinbelow. If the ME chooses to treat, a real time remotecontrol signal 22 is received by 20 and sent to 16. The logic device isoperative to pass two types of control signals to the medical treatmentdevice which it controls, (a) remote signals 24 which initiallyoriginate with the ME, and (b) local signals 28 generated by the logicdevice, based on its analysis of 15.

The logic device may prioritize among ME control signals 22 and its owncontrol signals in a variety of ways:

a) It may always give priority to ME control signals over its owninternally generated control signals; In such a situation, followingnotification, only the loss of communication with the MP would result inlocal control (i.e. control of the

b) In the presence of ME control signals, it may not even generate itsown control signals;

c) It may always provide therapy unless there is a specific signal 22which inhibits its providing therapy;

d) It may provide therapy along with the ME in an “OR” logic fashion,such that either one may cause 16 to cause 26 to treat.

Memory device 17 is linked to the logic device. It may be used for thestorage of information about patient events, the storage of programs formedical treatment device management and sensor signal processing, thetemporary storage of information during a communication exchange with aME, the storage of write-once-only information, and the storage of rulesfor notification management.

FIG. 2A shows an embodiment of the invention in which IMD 10communicates through it first T/R, with a second T/R device 40. 40provides signals representing a medical state of a patient 42 to bedisplayed on display device 44. First input device 46 allows an ME tosend real time remote control signals to 40, for transmission to 20. 10and at least one sensor 34 is implanted inside the body of a patient 36.Examples of possible sensors include a pacemaker wire (for sensingcardiac electrograms), a defibrillator lead, a transducer for measuringglucose concentration, a system of conductors for measuringtransthoracic impedance, etc. In the embodiment of the invention shownin FIG. 2A, sensor information from 34 is coupled to the sensor circuit38. IMD 10 transmits the information representing the sensor information(which may be the actual sensor information) via 20 to 40, for displayby 44. A human ME may then determine the appropriate treatment, andinput it to 46. Signals 48 representing the treatment are transmittedfrom 40 to 20, thereby to affect the function of 10.

FIG. 2B shows an embodiment of the invention in which the ME is amedical expert program or group of programs which run on a computationaldevice 50. Each of the signals to and from the first T/R (18, 22 and 32in FIG. 1) are transmitted between first T/R device 20 and the 2^(nd)T/R of shown herein 52. A device such as 50 would have advantages overthe logic device of the IMD including: (a) a much larger memorycapacity, such that information may be stored concerning (i) othermedical data from this patient; (ii) other medical data from otherpatients with a similar condition, (iii) performance data about IMD 10;(b) ability to update the database for 52 easily and frequently; and (c)ability to update the algorithms run by 50 easily and frequently.

FIG. 2C shows an embodiment of the invention in which IMD 10 in patient36 communicates with a computer ME 60, which in turn communicates with ahuman-based ME 70. First communication device 62 in 60 communicates withsecond communication device 72 in 70; the communication may be eitherwireless, indicated by signals 66 or wired, indicated by signals 64. Thefunction of 74 is analogous to that of 44 in FIG. 2A, and the functionof 76 is analogous to that of 46 in FIG. 2A. The route of the human realtime remote control signal is from 76 to 72 to 62 to 63 to 61 to 11 to10. In an alternate embodiment, the human control signal could becoupled from 62 directly to 61. In yet another embodiment, an RF signalfrom 72 could be sent directly to 11. The human ME may use each of thefollowing in the process of making a decision: (a) signals (processedand unprocessed) from one or more sensors 35 in patient 36, (b) signalsindicating the analysis by the logic device of IMD 10, and (c) signalsindicating the analysis by expert logic device 63. There are numerouspossible relationships which determine dominance, in terms of control,among each of (i) the human ME, (ii) device 63, and (iii) the IMD logicdevice. For example:

a) in one embodiment of the invention, human ME signals, if received bythe logic device of IMD 10 take precedence over control signals whichmay have been generated by the IMD logic device and over control signalsgenerated by the analysis of the medical data by 63;

b) in another embodiment, the human may be overruled if both 63 and theIMD logic device disagree with the human;

c) in another embodiment, an “OR” logic prevails, and any one of the IMDlogic device, 63 or the human ME may cause therapy to be delivered;

d) in another embodiment, “AND” logic prevails, and therapy is deliveredonly if each of the human and 63 and the IMD logic device indicate thattreatment is desirable; and

e) in another embodiment, any two of the three of the human ME, 63 andthe IMD logic device will dominate.

To reliably maintain a system in which the control of an implantedmedical device is shared or given over to an outside agent, all possiblemeans to maintain communications integrity must be undertaken.Techniques for improving reliability include but are not limited to: (a)redundant communications, (b) the ability to change a route (e.g. wiredvs. wireless [though at some point there must be a wireless segment forthe implanted device), (c) the ability to change a communications mode(e.g. different means of signal encoding, as is known in the art), (d)the ability to change power output of an RF or other electromagneticdevice, (e) the ability to change the sensitivity of a receiver, and (f)the ability to change frequency or channel or telephone number orinternet provider.

Furthermore, it is important that each of the communicating agents beable to determine whether each segment of the communication path (ineach direction) is operative, on a real time basis. For example, if theIMD logic device determines that there has been a break in communicationwith the ME, it must immediately (a) revert to autonomous operation, and(b) take whatever corrective means it can to restore propercommunication. Thus, one embodiment of the invention is operative tocause immediate restoration of device control by the IMD logic device,in the event of a break in communications. To accomplish this, ahandshaking routine is operative. FIG. 3A shows the routine at the IMD,and FIG. 3B shows it at the remote station. (Hereinbelow, communicationbetween the IMD and the remote station through one or more relay devicesis described. Handshaking routines, known in the art, are possiblebetween (a) each ‘adjacent’ communicating component in a string ofdevices, as well as (b) an overall handshake between the remote stationand the IMD.

Referring to FIG. 3A, which shows one possible semi-continuoushandshaking routine at the IMD, following the transmission ofnotification signal 100 by the IMD, an interval of time measured byclock 102 is allowed to elapse, waiting for a response, in the form of aremote station handshake signal. If the remote station handshake signalis received in a timely manner, block 104 leads to blocks 106 (resultingin the transmission of an IMD handshake signal by the IMD) and 108, adeclaration of the presence of proper communications. The presence ofproper communications allows for a second IMD operating mode, in whichthe IMD is controlled remotely. Block 106 leads to another waitingperiod determined by 102. In the presence of proper communications, theflow diagram will continuously cycle from 102 to 104 to 106 to 102.However, if there is an interruption in communications, such that aremote station handshake signal is either not received, or not receivedin a timely manner, block 104 leads to 112 and the declaration of theabsence of proper communications. 112 leads to 114 and a first IMDoperating mode. In the first operating mode, the IMD is controlled onlyby the IMD logic device. In this case, 104 also leads to 116, whichlists a menu of options directed at restoring proper communicationincluding: (a) repeat transmission of the remote station handshakesignal without any other change; (b) change in either mode, route, poweror channel/frequency, (c) change in the sensitivity, selectivity orother receiver characteristics of the IMD receiver (not listed in thefigure), (d) change in the characteristics or choice of an upstreamcommunications relay unit (see below), etc. Each of these choices thenleads to another handshake attempt, and another waiting for a response.

It may be possible to determine whether a break in communicationoccurred in the IMD to remote station direction, or in the reversedirection by the sending and receiving “communication failure” signals.Thus if the IMD receives 118 a second communication failure signal, itimplies that the remote station to IMD leg is intact, and it is the IMDto remote station leg that has failed. This helps direct remedialaction. Among the items in menu 116 is the sending of a firstcommunication failure signal, to allow the remote station to gain somediagnostic information about the source of the handshake interruption.

FIG. 3B shows one possible version of a handshaking routine at theremote station. Although the determination of a break in communicationis far more important at the IMD end (i.e. so that the IMD may resumeautonomous function immediately), there are remedial actions that can beaccomplished at the remote station end, therefore making the detectionof a handshake interruption valuable at that end as well. At block 150,the notification signal is received from the IMD, leading to thetransmission of a remote station handshake signal at 152. If after asuitable delay measured by clock 154, there is no received IMDhandshake, 156 leads to 158, with a menu of remedial options which areanalogous to those in block 156. The intact handshake loop in thediagram is 156, 152, 154, 156. The broken handshake loop is 156, 158,156, 158.

Many other approaches possible handshaking protocols and apparatus willbe obvious to those skilled in the art.

Finally (see hereinbelow), downloading a treatment plan or routine for acurrently happening ME-IMD session, for storage in the IMD memory, mayallow for the completion of a ME set of treatment steps which wereinterrupted by a break in communications.

Many implanted devices have a low battery drain and a longevity measuredin years. If the same battery that supplies a minimal amount of energyfor device function (e.g. cardiac pacing, where the current drain may be10-20 microamps or less) must also supply a transmitter, then unlessthere is judicious power management, there may be substantial shorteningof device battery life. Among the options for accomplishing this are:

a) programming notification criteria so that the function is notover-used;

b) the placement of one or more relay units (see below) in proximity tothe IMD/patient, so that transmission from the first T/R involves onlyshort distances;

c) methods of powering down the first T/R, partially, during atransmission, if possible;

d) monitoring battery function so that as the battery ages, the criteriafor notification may be made more restrictive;

e) letting the ME know the battery status during a transmission, so thatthe ME, recognizing an aging battery or batteries, may take action toshorten the current transmission and limit future ones, perhaps byeither (i) remotely reprogramming notification criteria, or (ii)remotely programming transmitter power consumption;

f) having a dual power supply arrangement, where one power supply powersonly the device T/R (or only the device transmitter), and one powersupply powers everything else in the device. An alternate embodiment ofthis approach would be to the transmitter (or T/R) battery or batteriesto be rechargeable.

Four exemplary ways of handling battery management are illustrated bythe embodiments of the invention shown in FIGS. 4A-4D. Hereinbelow, theword battery may refer to a single cell, two or more cells in series,two or more cells in parallel, and may refer to combinations of these.FIG. 4A contains a single battery 200 which supplies each of thecomponents of the IMD. In addition to supplying the components discussedhereinabove in conjunction with FIG. 1, the battery also suppliesbattery monitoring apparatus 202 with energy. 202 monitors one or moreof battery voltage, cell impedance, battery current drain, the droop incell voltage with increased demand, and indirect measures of batteryfunction (e.g. the charge time of an ICD). The battery information issupplied to the IMD transmitter 206, for transmission to remote station208, for assessment by the ME. The ME may use the information formanagement of real-time power consumption (i.e. reduce transmitter powerduring the current encounter) by sending a signal to receiver 210, whichpasses the information contained therein to transmitter 206.Alternatively, the MP may reprogram device performance (e.g.notification criteria), by sending a programming command from 208 to 210to the logic device (which coupling is not shown in FIG. 4A, but isindicated in FIG. 1.

FIG. 4B shows a one battery management approach where management isdirected within the IMD, i.e. by the IMD logic device. Information 236about battery 240 (similar to the information discussed hereinabove inconjunction with FIG. 4A) is processed by logic device 220, and may beused maximize the longevity of the battery, as discussed hereinabove.Besides power reduction signals 234 which reduce transmitter 230 powerby a variety of possible values, a signal 232 may be sent to power 230off. As indicated, 220 may also reprogram itself to accomplish suchgoals as altered notification criterion.

It is possible to combine the attributes of the power conservationapproach shown in each of FIGS. 4A and 4B.

FIG. 4C shows a dual power supply approach to power management. As shownin the figure, battery 252 powers the device components except for thedevice T/R 253 (and perhaps the battery monitoring apparatus 254), whichare powered by battery 250. Battery information moves from 254 totransmitter 256 to remote station 258 for evaluation by the ME. The MEmay control transmitter characteristics by sending a signal from 258 toreceiver 260 to transmitter 256. In addition, the presence of a secondbattery gives the ME some additional options: the use of one of thebatteries to perform the function of the other. Thus if battery 252,which controls the IMD in general, is nearing its end of service, andtransmitter battery 250 has a substantial remaining energy supply, theME may cause switching apparatus 262 to divert some or all of 250 energyto perform the functions intended for battery 252 (i.e. non-transmitterfunction). Similarly, the MP may do the mirror image diversion: In asituation with good 252 energy supply, poor 250 energy supply and theneed for an urgent interaction with a ME, switching apparatus 264 maydivert energy to transmitter 256 that might otherwise not have been ableto be supplied by 250. The ME could learn about the status of battery252 by information passed along the link from it to 254, and thence to256 and 258.

FIG. 4D shows a 2 battery configuration, with energy management by theIMD logic device. All of the functions performed by the apparatus inFIG. 4C could be performed by that in FIG. 4D, except that the source ofmanagement commands is logic device 270. 270 processes information 274about the status and projected longevity of 272, and may use it toeither (i) make one or more reductions 278 in the power consumption of280, or (ii) turn off 276 the transmitter.

A wide variety of possible triggers for ME notification are possible.FIGS. 5A and 5B illustrate a situation in which a single parameter (e.g.heart rate) is monitored to determine device action. Conventional ICDs(which include pacemaker function) are programmed to treat tachycardiaswhich are above a certain heart rate, and bradyarrhythmias whose rate isbelow a certain heart rate. The scenario illustrated by FIG. 5A shows ascenario in which a range of rates which is intermediate between thehigh rate, at which treatment is definitely required, and the normalrate, may be defined as the notification range of rates. For example, anICD might be programmed to:

a) notify for rates from 140 to 160 bpm and to treat and notify forrates above 160 bpm. The ME, upon notification, would decide whethertreatment is required for a rate of say, 150 bpm, and if so, cause theICD to provide such treatment. The ME might decide (a) to try somegentle treatment such as a non-aggressive anti-tachycardia pacing forthe situation, (b) to go ahead and provide aggressive treatment, or (c)to not treat at all. In the latter case, the ME might decide to checkthe patient at some later time, e.g. by leaving an instruction in theICD for the ICD to check in with the ME in 30 minutes. The ME mightfurther program altered “second notification” criteria, i.e. if therhythm normalizes, then over the next 24 hours, the threshold fornotification is lower (e.g. 130 bpm).

b) notify for rates from 140 to 160 bpm and to treat (and not notify)for rates above 160 bpm. [This is not shown in the figure.] This savesbattery in cases where there is little or no uncertainty about whichtherapy is the appropriate one.

In the figure, a similar format is programmed for bradyarrhythmia. Forexample, the pacing circuits may treat when the rate declines to 40 bpm,but may be programmed to notify for rates in the range of 40 to 50 bpm.Alternatively, the programming person might choose not to notify forpacing at 40 bpm (i.e. treat without notification).

FIG. 5B shows a format in which the ME is notified (and treatment isgiven) for values of a parameter that are extreme but not for valuesthat are only moderately abnormal. For example, the ME might be notifiedfor tachycardia that was treated whose rate was 260 bpm, but not fortachycardia which were treated with rate less than 200 bpm.

The aforementioned scenarios reflected by FIGS. 5A and 5B concern rathersimply notification criteria. More complex ones may depend on theresults of multiple different parameters from multiple sensors, andtheir evolution over time. Still more complex scenarios may depend notjust on the measured values of these parameters, but complexmathematical functions of them.

Once notification has occurred, the other dimension of interactionbetween the IMD and the ME, is how much control the ME has access to,following notification. FIG. 6A shows a scenario in which the ME isgiven essentially complete control. The right hand side of the figureshows the essential features of operation when the device operatesautonomously. Following detection of a parameter value 302 whichrequires therapy, the device applies the pre-programmed therapy 308, andoptionally transmits a confirmation signal, block 310, indicating thattherapy has been provided. However, if notification criteria have beenmet, 312, the IMD sends a notification signal, 314, for receipt by aremote station, and awaits a response, 316. Once the ME is incommunication with the IMD, the ME may both positively and negativelycontrol the device; That is, the MEP may choose to inhibit (block 318 to306) an action that the device, if operating autonomously, would haveperformed. Alternatively the ME may choose to cause the device todeliver therapy, even though the IMD program may not have called forthis. In such a circumstance, block 318 leads to 320, in which an MEcommand is decrypted and decoded, and then to 322, in which the therapyinstructions are carried out, followed by the sending of confirmationsignal 324.

Since the establishment of a communication link between the ME and theIMD may take a short time, an optional delay 304 is added in before theIMD acts autonomously, in a situation when notification has occurred.This is indicated by block 312 inducing optional delay 304, to preventautonomous IMD therapy before the ME can be involved.

The ME has a number of options for influencing the management of futureevents post notification, shown in block 326. In a preferred embodimentof the invention, the ME may reprogram (a) notification criteria, (b)the definition of what constitutes and abnormality, in terms ofautonomous device functioning, (c) aspects of sensor signal analysis,(d) the details of therapy during autonomous device functioning, (e)communication management [route, mode, channel, etc.], (f) batterymanagement, (f) followup management (the ability of the ME to ask for acallback from the IMD) after a ME-managed-event, to report patientstatus), and (g) communication termination management (e.g. how longuntil communication ends after [i] a successfully managed event, and[ii] an event in which communication failed during the event).

FIG. 6B shows another management scenario. Two operating modes aredefined for the IMD. In a first operating mode (O.M.=1, in the figure)the IMD logic device is in control of therapy, while in a secondoperating mode (O.M.=2, in the figure), the ME is in control. Thescenario shown in 6A involved moment to moment choices by the ME ofwhether to inhibit an IMD function; In the scenario in 6B, all IMDfunction is inhibited in the second operating mode, unless (a) the MEchooses to return the control to the IMD (block 350 to 352 via brokenline indicating optional feature), or (b) communication fails [350 to352 via solid arrow]. In other aspects not explicitly mentioned, thealgorithm in FIG. 6B is identical to that of 6A.

FIG. 6C shows a different algorithm. In this case, the decision betweenremote and local management is made (a) early on [i.e. before the ME isinvolved], and is made by the logic device of the IMD. Other aspects ofthe figure not specifically discussed are similar to those in alreadydiscussed figures.

FIG. 6D shows another algorithm in which the remote station (RS) isgiven a particularly high level of priority. If an abnormality isdetected by the IMD which may require treatment 360, signals aretransmitted to the ME 362, at which point, two determinations are made:(a) Is therapy warranted [block 364]? and (b) Is the source oftherapy-related choices to be local (i.e. the IMD) or remote (i.e. theME)[block 366]? If the source of therapy is to be local, the ME returnscontrol to the IMD. Other aspects of the figure not specificallydiscussed are similar to those in already discussed figures.

Other scenarios in which the ME does not have top priority have beendiscussed hereinabove.

Since battery conservation is a major concern with IMDs, and sincewireless communication is a feature, the most efficient way to managesuch devices is to provide one or more relay units between the IMD andthe ME. Having one such unit in close proximity to the IMD will help tolimit IMD battery depletion. Many possible relay units may be designed,and are known in the art. The essential features of such a unit areshown in FIG. 7. A fourth transmitting and receiving device, “fourthT/R” 370 communicates wirelessly with the first T/R 372 of the IMD 374.370 is linked within relay unit 376 to a third T/R 378. Thecommunication of the third T/R with the remote station 382 is via thesecond T/R 380. The communication between 378 and 380 may be wired(broken line) or wireless. It may involve no intervening communicationdevice, or a number of such devices. It may involve a public telephonecarrier or a private network, and may involve the Internet.

376 contains telecommunications control unit 384, which may adjust theoperating characteristics of the third T/R to optimize communicationwith the remote station, and adjust the operating characteristics of thefourth T/R to optimize communication with the IMD. An optional secondinput device 386 could allow a local person or the patient to have someor complete control of the IMD; An optional third input device 388 couldallow a local person or the patient to send a signal (e.g. anotification signal) to the ME. This could be used in a case where thepatient feels that observation and potential ME intervention iswarranted.

The following description details a preferred embodiment of theinvention, entailing an ICD as the IMD. “MP” refers to a medicalprofessional, which is the human version of the aforementioned ME.

Hereinabove and hereinbelow, ICD is intended to include:

A) devices which can administer a defibrillation shock; and

B) devices which can administer a defibrillation shock and canadminister cardiac pacing. It is to be understood that this technologymay be used in any implantable medical device, and any remotelycontrolled critical system.

FEATURES OF THE INVENTION

1) The Implantable Cardioverter Defibrillator (“ICD”) may initiate thecommunication between itself and the Central Station (“CS.”) Mechanismsfor this are illustrated.2) The “control unit” referred to in Ser. No. 10/460,458 may be:

A) a cellular telephone or other personal communication devices (such asa Blackberry( ) as are known in the art.

B) the Stationary Unit referred to in Ser. No. 10/460,458; and

C) any relay unit whose purpose is to amplify the signal as it is passedalong between ICD to CS.

Hereinbelow, the unit which serves as the communications hardware linkbetween the CS and the ICD shall be referred to as the repeater unit(“RU”).

3) Means within the ICD may select alternate mode of communication (e.g.a public or private telephone network, or the internet) and may selectalternate routes of communication (e.g. in a multi-segmentcommunication, selecting each segment of the total communications link.4) Handshake signals may be exchanged between:

A) the CS and the RU;

B) the RU and the ICD; and

C) the CS and the ICD.

The handshake signals may be used to indicate the presence or absence ofcommunication signals between two components (e.g. the ICD and the RU)or to indicate the quality of the signals.5) If the handshake signals indicate either an absent communicationslink or a poor quality one, the handshake signals may be used to causethe ICD to:

A) select an alternate mode of communications;

B) select an alternate route of communications;

C) increase the power output of the ICD transmitter;

D) increase the sensitivity of the ICD receiver.

6) The communications route from the ICD to the CS may involve multiplesegments. These segments may include:

A) an ICD to RU segment;

B) one or more RU to RU segments;

C) a RU to CS segment; and/or

D) a direct ICD to CS segment.

7) Ser. No. 10/460,458 presents two formats for ICD control by aremotely located medical professional (“MP”):

Format A) In one (claim 219 and the 24 dependent claims which follow),the MP has primary control, and, in the absence of proper communicationbetween the ICD and the MP, the ICD is in control;

Format B) In the other (claim 244 and the 25 dependent claims whichfollow), the ICD has primary control. The MP may overrule the ICD on atherapy decision, if he deems this to be desirable.

Feature 7 presents an approach in which the choice between Format A andFormat B may be:

A) “hardwired” into the ICD;

B) irreversibly programmable (using a PROM, EPROM, EEPROM, etc., as isknown in the art)

C) programmable by the medical professional who is responsible forprogramming the patient's ICD an a routine basis;

D) programmable by the MP, at the time of a medical emergency which hascaused the ICD to communicate with the MP; and/or

E) programmable by the ICD, at the time of a medical emergency which hascaused the ICD to communicate with the MP.

8) When the ICD initiates a communication with the CS, there may be a2-or-more tier format such that:

A) 2 or more levels of emergency are defined;

B) for each level, a greater degree of “communications aggressiveness”(on the part of the ICD) is defined.

For example:

2 levels of emergency:

-   -   Moderate emergencies include ventricular tachycardia (“VT”) at        rates less than 160;    -   Major emergencies include a) VTs at rates greater than or equal        to 160 and b) VTs or ventricular fibrillation (“VF”) requiring a        shock.

The corresponding two levels of communication aggressiveness would be:

-   -   For Moderate emergencies: a) no ICD transmitter output power        boost (see below); and b) a small number of repeat attempts by        the ICD to contact the CS; and    -   For Major Emergencies: a) one or more ICD transmitter output        power boosts; and b) a large number of repeat attempts by the        ICD to contact the CS.        Examples with 3 or more levels are obvious.        There is also the possibility of moderate emergencies (or the        lowest level of emergency in a three or more level setup)        resulting in no attempt at communication by the ICD.        9) Referring to 8) above, the definition of each level of        emergency may be:

A) “hardwired” into the ICD;

B) irreversibly programmable (using a PROM, EPROM, EEPROM, etc., as isknown in the art)

C) programmable by the medical professional who is responsible forprogramming the patient's ICD an a routine basis;

D) programmable by the MP (after communication between the MP and theICD has been established), at the time of a medical emergency which hascaused the ICD to communicate with the MP; and/or

E) programmable by the ICD (after the event which calls for acommunication between MP and ICD);and/or

F) programmable by the ICD (during the event which calls for acommunication between MP and ICD), if ICD circuitry determines thatbattery conservation requirements dictate a shut-down of thecommunication link.

10) Options based on battery reserve of ICD:

If hardware/software within the ICD determines that the ICD batteryreserve is low, ICD options include:

A) terminate the communication;

B) send a message to the MP indicating the low reserve, and thenterminate the communication;

C) lower power output and attempt to continue the communication; (Thisstep may be repeated one or more times.); and/or

D) continue the communication with output as is, and repeat assessmentat a future time.

11) End of communication options:

The communication may end:

A) because of low ICD battery reserve, see Feature 10), above;

B) because the MP determines that further communication is notwarranted; and/or

C) because the ICD logic unit determines that further communication isnot warranted.

12) Identification-related issues:

Privacy in the communication between the ICD and the MP to bemaintained:

A) Encryption and decryption per means and methods:

-   -   i) in Ser. No. 10/460,458; and    -   ii) others, known in the art;

B) An identification system wherein any ICD requires proof of MPidentification, before and during and communication session.

13) The download of contingency plans from MP to the ICD, as soon aspossible after the exchange of information begins. The purpose of thecontingency plan download is to have a management strategy in placewithin the ICD, should the ICD-MP communication get interrupted midwaythrough the event. Although the basic system calls for the ICD to revertto its programmed behavior in the event of communications interruption,the MP may desire to leave a temporary plan in place, to be used for theremainder of the current medical event. The MP may update thecontingency plan as needed, as the medical event progresses.

An example of such a contingency plan would be more aggressive (or lessaggressive anti-tachycardia pacing, prior to defibrillator shock).Another example would be to eliminate all intermediate energy shocks,and deliver only high energy shocks. Numerous other examples will beapparent to those skilled in the art.

Referring to the figures, which show additional documentation of themeans and methods of accomplishing the above 13 features:

FIG. 8 shows a patient 400 with and ICD 402 which communicates with a MP404 at a MP communication station 406. 406 may be a central station asdescribed in Ser. No. 10/460,458 or a central or peripheral station asdescribed in Ser. No. 11/502,484. The ICD antenna is not shown, but inFIGS. 8-10, it is to be understood that the ICD has one or more antennawhich allows it to properly communicate.

The communication route is in either direction between:A) the T/R device within the ICD; B) the T/R device within personalcommunication device 410; and C) the T/R device within the MPcommunication station.The communication route may also be directly between the T/R devicewithin the MP communication station and the T/R device within the ICD.Referring to FIG. 9: It is also possible to have two or moreintermediate communication links between the ICD T/R and the T/R of theMP communication station. In FIG. 9, there are 2 personal communicationdevices 1200 and 1202 and a repeater unit 1204 (as discussed above).Possible arrangements include:A) two or more personal communication devices and no repeater units; B)one or more repeater units and no personal communication devices; and C)one or more repeater units and one or more personal communicationdevices.It is also possible that the communications route would change during asingle medical event. This would occur if either the MP or thehardware/software within the ICD determines that a change of route isdesirable.The antenna shown for 406 may, at times, not be used, since at times,communication with 406 may be via “land line.”FIG. 10 shows that each segment of the communication route may be:A) via satellite(s) (1300, 1302 and 1304 in the figure, each of whichmay represent a single satellite or an array of multiple ones); B) via anon-line-of-sight radiofrequency link (1310, 1312, 1314); C) via aline-of-sight radiofrequency link (1316, 1318, 1320); D) via a public orprivate telephone network; E) via cell-phone and/or personalcommunication device network (1322, 1324); F) in the links beyond theICD link, via “land lines 1308;” and/or G) combinations of A-F.The PCD 1326 in figure PCD in FIG. 10 may be replaced by a wirelessrouter such that the communication between the ICD and the MP is ICD1328.rarw..fwdarw.wireless router.rarw..fwdarw.internet.rarw..fwdarw.MPcommunication station 1330. The route from the wireless router to thecommunication station can have a wide variety of configurations, as isknown to those skilled in the art.FIG. 11 shows one possible algorithm for allowing the ICD to communicatewith a MP communication station, with or without an intervening repeaterunit/cell phone/stationary unit/control unit.If/when the ICD detects an abnormal heart rhythm that requires action,may require action or requires analysis, block 1400, it determineswhether the rhythm requires communication with the MP. One method ofdetermination is to classify rhythm abnormalities as either major or notmajor, and to communicate if the rhythm abnormality is major. Thisdetermination is made at block 1402.The figure shows a setup with two levels of emergency, as described inFeature 8, hereinabove. If the rhythm is determined, block 1402, not tobe a major emergency, but is a moderate emergency, block 1404, thencontinued monitoring, bock 1406, is in order, to monitor for thepossibility of the event turning into a major emergency; If this occurs,return to block 1402, and proceed with major emergency section of thealgorithm. If there is neither a major nor a moderate emergency, block(either because the emergency condition has resolved, or because thereis an abnormality which is less urgent than even the moderate category),the algorithm shown in FIG. 11 ends. ICD monitoring, of course,continues as always.If a major emergency is detected, block 1410, the ICD T/R is turned on.Not leaving it on continuously saves the battery charge. The ICD thenattempts to contact the MP, block 1412. A handshake protocol, which mayhave some or all elements of that described in Ser. No. 10/460,458 ormay have one or more features of other handshaking protocols as areknown in the art, ensues, block 1414.If the handshake is unsuccessful, or (optionally) if the quality of thehandshake is sub-optimal, block 1416 lists six possible options. Theseinclude:

1) repeat attempt at handshake, using the same communication parameters;

2) change communication mode (as defined in Ser. No. 10/460,458) andrepeat handshake attempt;

3) change communication route (as defined in Ser. No. 10/460,458) andrepeat handshake attempt;

4) increase ICD transmitter power and repeat handshake attempt;

5) wait, and then repeat the handshake attempt, either with the sametransmitter/mode/route parameters or one of more altered ones; and/or

6) suspend efforts to contact the MP.

In the case of the options 1-5, block 1416 leads to block 1412: a repeatattempt to contact the MP.In the case of option 6, block 1416 leads to 1408 and the algorithmends. Option 6 may be selected after a pre-programmed number of attemptsto reach the MP has occurred.Alternatively, the number of attempts may not be pre-programmed and maydepend on the ICD battery status (see hereinbelow), or the level of theemergency.If the handshake is successful, than the MP will have the opportunity toparticipate in the management of the emergency. The format for suchparticipation is:

a) pre-programmed Format A (MP control is primary; ICD control is in theevent of communications interruption);

b) pre-programmed Format B (ICD control is primary; MP control in theevent that the MP chooses to override the ICD decision);

c) either Format A or Format B, with the choice made by the MP at thetime of the event; or

d) either Format A or Format B, with the choice made by the ICD based onthe severity of the event.

As indicated hereinabove, the aforementioned Format selection is made,block 1418, leading to either Format A/block 1420, or Format B/block1422. Thereafter the MP either manages, co-manages (with the ICD) orobserves the emergency event, block 1424.The communication between the ICD and the MP may terminate in one ofthree ways:A) by necessity, because the ICD battery has reached a point in itsdischarge, where it is deemed unwise to continue communications;B) due to the heart rhythm-related emergency having been resolved; orC) due to an unintended interruption of communications.In the event of A), block 1424 leads to 1426, which leads to a MPnotification, block 1428. This may be followed by:

1) The ICD immediately turning off its T/R, block 1430;

2) The MP deciding to immediately turn off the ICD T/R, block 1430, or,

3) block 1424, the MP deciding to take some additional time tocommunicate, despite the low battery warning.

Algorithms which omit the warning to the MP of impending ICD T/R shutoffare possible.In the event of B), block 1424 leads to 1426, which leads to 1432, whichleads to 1430.In the event of C), attempts to re-establish communication occur, asdescribed in Ser. No. 10/460,458. During the time when communication hasnot been established, the ICD logic unit manages the case.To avoid a situation where the ICD logic unit must takeover in themiddle of an event which the MP was managing in a different manner thanwould have been executed by the logic unit, the MP may, from time totime download contingency plans to the ICD, block 1434, such that, inthe event of an interruption, the ICD has enough of the current MPdecision making algorithm to complete the management of the event. Thisapproach is discussed hereinabove, as Feature 13.FIGS. 12 to 29 present apparatus, methods and approaches to securingdual IMD control i.e. [1] control by the internal/pre-programmed devicemanagement algorithm and [2] management control by an external source.The external source may be located remotely, nearby or may even be thepatient himself/herself. The identification means presented hereinbeloware presented in applicant's U.S. patent and applications U.S. Pat. No.8,233,672, Ser. Nos. 12/714,649, 13/563,399, and 13/834,634, which areall incorporated herein by reference.FIG. 12 shows a remotely and internally controllable IMD whichdetermines the identification of a person wishing to remotely controlthe IMD 1510. Processor 1500 receives signals containing physiologicinformation from sensor circuit 1502. The internal control algorithmleads to the “local treatment device control signal”. Alternatively, asindicated hereinabove, 1500 may notify an external control source(person or device) via T/R device 1504, of the detection of a medicalabnormality by sensor circuit 1502; processor 1500 may also cause thetransmission of information representing the medical state detected by1502, as indicated hereinabove. If the external source is to controlthis secure form of the IMD, the source must provide both (i) incomingidentification information and (ii) control information (specifying acommand, a device action, a temporary or permanent reprogramming etc.).These are received by 1504 and provided to 1500. External control, ifauthorized, leads to the generation of an external treatment devicecontrol signal. As indicated hereinabove in conjunction with FIGS.6A-6D, the treatment device 1508 may be controlled by either of the twosources, with a variety of prioritizing algorithms. Memory device 1506stores identification information of allowed users, as discussedhereinbelow, and may store information and programs related to theoperation of each of the device's systems, as is known in the art.FIG. 13 shows a system with a remotely and internally controllable IMD1540 which determines the identification of a person wishing to remotelycontrol the IMD, and a remote control device 1560 with a single inputdevice 1550 for inputting both user identification and user devicecontrol information. Memory 1552 may store (i) operating programs forthe control device, and (ii) identification information of allowed usersas will be described hereinafter with reference to FIGS. 19 and 20.FIG. 14 shows a system with a remotely and internally controllable IMD1600 which determines the identification of a person wishing to remotelycontrol the IMD, and a remote control device 1610 with a single inputdevice 1602 for inputting both user identification and user devicecontrol information. Presentation device 1604 presents information forthe user. 1604 may be a screen of a computer system, a smartphone,television or any device for presenting visual information.Alternatively, it may a device for presenting audio information such asa speaker, earphone, smartphone, telephone, television etc.FIG. 15 shows a system with a remotely and internally controllable IMD1620 which determines the identification of a person wishing to remotelycontrol the IMD, and a control device 1630 with two inputs: one forinputting identification information 1632, and another one for inputtingdevice control information, 1634.FIG. 16 shows a system with a remotely and internally controllable IMD1650 which determines the identification of a person wishing to remotelycontrol the IMD; and a remote control device 1660 with two inputs: acamera 1662, and a second input device 1664. As shown in the figure thecamera may image the control information input device 1664, whichprovides enhanced user identification, as discussed hereinbelow.FIG. 17 is a diagram of the system of FIG. 13, with a camera 1700providing a composite image showing both control and identificationinformation. In the particular embodiment shown in the figure 1700images a keyboard 1702 from below. The keyboard has semitransparentkeys, allowing the observation by 1700 of both a keyboard entry and abiologic identifier—a fingerprint—as the associated finger inputs thekeyboard entry. The keyboard may be mechanical, virtual, a touchsensitive screen or any other such apparatus as is known in the art.Although one typical key array is shown, the keyboard may consist of anypattern of keys with any markings (e.g. “defibrillate” “pace”, etc.)The composite image output 1704 of camera 1700 is passed bycommunications system 1706 to IMD processor 1708. 1708 compares thefingerprint image information in memory 1710 (discussed hereinbelow)with identification information 1714 obtained from the composite imageto determine if the user attempting to gain access to the IMD isauthorized. If he/she is authorized, the choice of treatment selection1712 represented by image 1704 (indicated in the exemplary figure by theselection of the “D” key, but intended to be entirely general) isexecuted.In an alternate embodiment of the invention, 1708 compares image 1704with a library of images in memory, each image showing both a biologicidentification and a treatment selection, as shown in FIG. 20. Forexample, memory file 2002, labeled PRINT 1,1 contains data representingone image of fingerprint #1 of user #1 selecting treatment #1. 2004contains a representation of a second image of fingerprint #1 of user #1selecting treatment #1. 2006 contains a representation of fingerprint #2of user #1 selecting treatment #1, etc.Similarly, memory file 2012, also labeled PRINT 1,1 contains datarepresenting one image of fingerprint #1 of user #1 selecting treatment#2. 2014 contains a representation of a second image of fingerprint #1of user #1 selecting treatment #2. 2006 contains a representation offingerprint #2 of user #1 selecting treatment #2, etc.Similarly, the array below that which pertains to treatment #2, pertainsto treatment #3. One such array would be stored for each possibletreatment choice. And one such set of arrays would be stored for eachallowed/authorized user.In this alternative embodiment, the processor need not extract the IDimage and/or the treatment selection. That is, the two would beidentified “en bloc” as indicated hereinabove.Other means of image identification and analysis will be clear to thoseskilled in the art.FIG. 19 is another diagram of memory file notation and allocation in thedual control IMD system which addresses the confounding effects oflighting and image/camera relative geometry, and is discussed furtherhereinbelow.FIG. 18 is a diagram of the dual control IMD system with both camera andkeypad inputs. It differs from FIG. 17 in that keyboard selectioninformation 1802 is also supplied to processor 1806 (i.e. in addition tosupplying the composite image 1804 to the processor), both viacommunications system 1810. 1806 generates identification information1812 by either of the two approaches discussed hereinabove inconjunction with FIG. 17. Treatment selection information is obtainedeither directly from the keyboard information (1822, from 1802) or isobtained (by either of the two approaches discussed in conjunction withFIG. 17) as 1816, from composite image 1804. Comparison of thecamera-based treatment selection 1816, and the keypad-based selection1822, yields potential further security: It links keyboard output 1802to the fingerprint image 1812 in a more secure way than would be thecase if the keyboard entry was not part of the composite image. Memory1814 serves the same function as that of 1710 in FIG. 17.FIG. 21 illustrates the dual acquisition of biologic identificationinformation and control information. As discussed in U.S. Pat. No.8,233,672, camera 2100 images both (i) keyboard entries (via 2104) oftreatment commands and (ii) either (a) one or more the fingerprints via2104 or 2106, (b) a palm print or an image of hand/finger vasculaturevia 2106, or (c) a facial image of user 2102. Camera 2114 may image theface of 2102 or his/her keyboard selection via reflecting surface 2112.Alternatively 2114 may input the actions of the user inputting entriesto a touch sensitive screen 2110, and also image the face of 2102 in thesame image. Any of the cameras may also image iris relatedidentification features; camera locations for these acquisitions neednot be limited to those shown in the figure; numerous/limitless otherconfigurations are possible.FIG. 21 also illustrates the approach to dealing with a determinationthat (as opposed to the keyboard situation of FIGS. 17 and 18) anidentification image obtained from a body part (e.g. the face) which isnot the body part which inputs the treatment selection, is part of thesame individual as the body part which inputs a treatment selection.This is accomplished by imaging the contiguous body parts lying betweenthe source of the biologic identifier and the body part making thetreatment selection. Thus camera 2100 may image face 2120, arm 2122,hand 2126 and keyboard entry using 2104 (without fingerprintidentification); In this case, the face is the biologic identifierlinked to the keyboard entry. (In actuality, the neck and upper leftportion of the torso would also need to be imaged to complete thecontiguous body part pathway.)The discussion of images hereinabove and below may refer to a singleimage or a plurality of images. The time interval between consecutivelyacquired images may be shortened to ultimately display semi-continuousmotion.FIG. 22 is a block diagram of an automatically operating remote controlstation 2200 for the dual control IMD, with identification of the remotecontrol station. A processor 2204 analyzes the information innotification signal(s) 2206 and thereafter renders a decision about IMDcontrol and/or management, transmitted to IMD 2210 as controlinformation 2208. Identification information 2212 pertains to thecontrol device and may “reside” in the processor (represented by 2202within 2204) or in a separate memory device.Biodynamic identification is the subject of material incorporated byreference. It refers to the remote manipulation of a biologic identifierby the entity that wishes further confirmation that the receivedbiologic identification information is authentic. A simple example isthe remote manipulation of the size of the pupil and iris of an eye asthe intensity of an applied light is remotely varied. Since the entityperforming the identification varies the light source intensity, and cando so in a way known only to that entity, defeating such a system (e.g.with an inappropriately obtained static iris image) will not bepossible.FIG. 23 is a block diagram of the use of prompts to identify a deviceuser, appearing in material incorporated by reference.FIG. 19 shows a memory arrangement intended to be useful for variablelighting and other orientation issues. Element 1902 “IRIS 1,1” indicatesa file representing one appearance of an iris of user #1 with lightingintensity #1. 1904 is a second example of the same iris of the sameperson, with the same lighting conditions on another occasion. 1906 isthe same iris with a different lighting intensity.Fingerprint data 1920, 1924 and 1926 are each analogous to 1902, 1904and 1906 respectively; and facial image data 1940, 1944 and 1946 areeach analogous to 1902, 1904 and 1906 respectively.FIG. 24 shows the response of the iris/pupil to various lightintensities. Pain and focusing efforts also change the size of thepupil/iris, also discussed in material incorporated by reference.FIG. 25 is a diagram of the user identified, dual control IMD with aremotely controllable light source supplying prompts 2502, a camera 2504and another (optional) input device; the prompts are controlled by theIMD processor (1500 of FIG. 12), and are transmitted by 1504 toreceiving device 2500—as taught by the aforesaid U.S. patent applicationSer. No. 13/563,399 (U.S. Patent Pub. No. 2012/0314048) in which FIGS.16B and 16C and the associated specification illustrate prompt controlby each of remote processors 1646 and 1670 respectively.FIG. 26 is diagram of the user identified, dual control IMD with a textsource 2602 supplying prompts, a camera and another input device. Thetext source may emit audio instructions requesting various actions ofthe user, e.g. change position of a certain body part, blink, etc. As inthe case of the embodiment of FIG. 25 herein, the IMD processor (1500 ofFIG. 12) is the source of the prompt selection.FIG. 27 is a representational block diagram of the user identified, dualcontrol IMD with a sound source 2702 supplying prompts, a camera andanother input device. The sound source may emit audio instructionsrequesting various actions of the user, e.g. change position of acertain body part, blink, etc. The IMD processor (1500 of FIG. 12) isthe source of the prompt selection.FIG. 28 is a representational block diagram of the user identified, dualcontrol IMD with a pain source 2802 supplying prompts, a camera andanother input device. As indicated in conjunction with FIG. 24, theapplication of pain may affect pupil/iris size. The IMD processor (1500of FIG. 12) is the source of the prompt selection.FIG. 29 is a representational block diagram of the user identified, dualcontrol IMD with a prompt producing device, a microphone 2900 andanother input device. Prompt producing device 2902 may issue video,audio or text instructions to a user to speak certain words. These wordsmay serve as the biologic identifier. A camera or other input device maysupplement this arrangement. The IMD processor (1500 of FIG. 12) is thesource of the prompt selection.

What is claimed is:
 1. Electronic medical apparatus adapted to beimplanted in a human patient, a so-called implantable medical device(IMD), which may be alternatively automatically self-controlled andexternally controlled by a properly identified medical expert, saidapparatus comprising, in combination: (a) a sensor circuit, having asensor circuit output, for producing at least one sensor circuit outputsignal at said sensor circuit output in response to medical data sensedfrom the patient; (b) a first transmitting/receiving (“T/R”) device fortransmitting the medical data sensed from said patient to an externallocation, and for receiving from said external location at least oneexternal signal representing (i) control information for the IMD, and(ii) incoming identification information (“III”) which identifies asource of said control information; (c) an electronic medical treatmentdevice for treating said patient; (d) a memory device, for storingidentification information indicating allowed sources of said controlinformation; and (e) a first processor coupled to each of (i) saidsensor circuit output, (ii) said first T/R device, (iii) said treatmentdevice, and (iv) said memory device; for (i) analysis of said at leastone sensor circuit output signal, (ii) generating an external stationnotification signal, (iii) generating at least one local treatmentdevice control signal, (iv) generating at least one external treatmentdevice control signal representing said control information; (v)comparing said III with said stored identification information (“SII”),and (vi) indicating an identification (“ID”) match upon a determinationthat said III and said SII are substantially similar; and wherein: (1)said first processor analyzes said at least one sensor circuit outputsignal to detect a medical abnormality which requires notification ofthe medical expert at the external location, and is operative togenerate a notification signal representing at least one medical stateof the patient for consideration by said medical expert when saidanalysis reveals said medical abnormality; (2) upon receipt of saidnotification signal, said first T/R device transmits said notificationsignal to the external location; (3) said first processor analyzes saidat least one sensor circuit output signal to detect a medicalabnormality which requires treatment and is operative to generate atleast one local treatment device control signal, if required; (4) uponthe determination of said ID match, said first processor is operative togenerate at least one external treatment device control signal inresponse to the control information represented by said at least oneexternal signal received from the external location by said first T/Rdevice; and (5) said treatment device delivers therapy, if required, inresponse to one of said at least one local treatment device controlsignal and said at least one external treatment device control signal;and whereby: (1) said processor determines whether to issue saidnotification signal, to issue said at least one local treatment devicecontrol signal, to issue both said notification and said at least onelocal treatment device control signal, or to issue neither saidnotification nor said at least one local treatment device controlsignal, based on said analysis, and (2) said first processor generatessaid at least one external treatment device control signal only uponreceipt of control information from a properly identified source ofcontrol.
 2. The apparatus defined in claim 1, wherein upon generation ofboth a local treatment device control signal and an external treatmentdevice control signal, said treatment device provides the treatmentspecified by said external treatment device control signal.
 3. Theapparatus defined in claim 1, wherein upon generation of both a localtreatment device control signal and an external treatment device controlsignal, said treatment device provides the treatment specified by saidlocal treatment device control signal.
 4. The apparatus defined in claim1, wherein said first processor is further operative to receive aninstruction specified by said control information specifying which ofsaid local and said external treatment device control signal shalldetermine the treatment provided if both said local and said externaltreatment device control signals are generated.
 5. The apparatus definedin claim 1, wherein said III includes information which identifies acontrol device which is the source of said received III.
 6. Theapparatus defined in claim 1, wherein said III includes informationwhich identifies a human medical expert which is the source of saidcontrol information.
 7. The apparatus defined in claim 6, wherein: (a)each of said control information and said III are inputted by a cameraand transmitted to said first T/R device, said camera being configuredto generate at least one composite image which includes both (1) an actof said human medical expert selecting a treatment selection, and (2) aunique identifying feature of said human; said treatment selectionindicating a treatment choice selected from a plurality of possibletreatment choices; (b) said SII represents at least one unique visualfeature of at least one human allowed to input said treatment selection;and (c) said first processor is further operative to: (1) determine saidIII based on a first analysis of said composite image, and to (2)determine said treatment selection based on a second analysis of saidcomposite image; and (3) generate said at least one external treatmentdevice control signal representing said determined treatment selection,if said III is substantially similar to said SII; whereby said controlinformation represented by said composite image generates said at leastone external treatment device control signal if said III represented bysaid composite image is substantially similar to said SII.
 8. Theapparatus defined in claim 6, wherein: (a) each of said controlinformation and said III are inputted by a camera and transmitted tosaid first T/R device, said camera being configured to generate as“composite III” at least one composite image which includes an act ofsaid human medical expert selecting a particular treatment selection,said image including both (1) said particular treatment selection and(2) a unique identifying feature of said person, said treatmentselection indicating a treatment choice selected from a plurality ofpossible treatment choices; (b) said memory device is operative to storeas composite SII, information representing composite images, each imageshowing an act of a treatment selection including (1) said particulartreatment selection; and (2) a unique identifying feature of aparticular human allowed to input a particular treatment selection, and(c) said first processor is further operative to (1) determine saidtreatment selection based on an analysis of said composite image; (2)compare said composite III with said composite SII and to determine saidID match if (i) said composite III and (ii) said composite SII aresubstantially similar; and (3) generate said at least one externaltreatment device control signal representing said determined treatmentselection, if said composite III is substantially similar to saidcomposite SII; whereby said control information represented by saidcomposite image generates said at least one external treatment devicecontrol signal if said composite III represented by said composite imageis substantially similar to said composite SII.
 9. The apparatus definedin claim 6, wherein: (a) each of said control information and said IIIare inputted by a camera and transmitted to said first T/R device, saidcamera being configured to generate as “composite III” at least onecomposite image which includes an act of said human medical expertselecting a particular treatment selection, said image including both(1) said particular treatment selection and (2) a unique identifyingfeature of said human; said treatment selection indicating a treatmentchoice selected from a plurality of possible treatment choices; (b) saidmemory device is operative to store as “composite SII” informationrepresenting composite images, each image showing an act of a treatmentselection including (1) said particular treatment selection; and (2) aunique identifying feature of a particular human allowed to input aparticular treatment selection, and (c) said first processor is furtheroperative to (1) compare said composite III with composite SII and todetermine both (i) said ID match, and (ii) said treatment selection,based on a determination of a substantial similarity between said IIIand at least one particular composite SII representing both: (A) aparticular allowed person and (B) a particular treatment selection; (2)generate said at least one external treatment device control signalrepresenting said treatment selection, if said composite III issubstantially similar to said stored III; whereby said controlinformation represented by said composite image generates said at leastone external treatment device control signal if said composite IIIrepresented by said composite image is substantially similar to saidcomposite SII.
 10. The apparatus defined in claim 6, wherein: (a) saidcontrol information is a treatment selection indicating a treatmentchoice by said human medical expert, selected from a plurality ofpossible treatment choices, inputted by a keypad and transmitted to saidfirst T/R device; (b) said III is inputted by a camera and transmittedto said first T/R device, said camera being configured to generate as“composite III” at least one composite image which includes both (1) anact of said human medical expert selecting said treatment selection, and(2) a unique identifying feature of said human; (c) said memory deviceis operative to store as “composite SII” information representingcomposite images, each image showing an act of a treatment selectionincluding (1) said particular treatment selection, and (2) a uniqueidentifying feature of a particular human allowed to input a particulartreatment selection; and (d) said first processor is further operativeto: (1) compare said composite III with composite SII and to determineboth (i) said ID match, and (ii) an image-based treatment selection,based on a determination of a substantial similarity between saidcomposite III and at least one particular composite SII representingboth: (A) a particular allowed person and (B) a particular treatmentselection; (2) determine a key pad-based treatment selection based onsaid received control information; (3) determine an input match,indicating that said treatment selection was inputted to said keypad bythe same human that inputted said III to said camera if said keypad-based treatment selection and said image-based treatment selectionare identical; and (4) generate said at least one external treatmentdevice control signal representing said determined treatment selection,if (A) said III is substantially similar to said SII and (B) said firstprocessor determines said input match; whereby said control informationinputted via said keypad generates said at least one external treatmentdevice control signal if both said ID match and said input match aredetermined.
 11. The apparatus defined in claim 6, wherein: (a) saidcontrol information is a treatment selection indicating a treatmentchoice by said human medical expert, selected from a plurality ofpossible treatment choices, inputted by a keypad and transmitted to saidfirst T/R device; (b) said III is inputted by a camera and transmittedto said first T/R device, said camera being configured to generate atleast one composite image which includes both (1) an act of said humanmedical expert selecting said treatment selection, and (2) a uniqueidentifying feature of said human; (c) said SII represents at least oneunique visual feature of at least one human allowed to input saidtreatment selection; and (d) said first processor is further operativeto: (1) determine said III based on an analysis of said composite image;(2) determine said treatment selection based on said received controlinformation; (3) determine an input match, indicating that saidtreatment selection was inputted by the same human that inputted saidIII to said camera; and (4) generate said at least one externaltreatment device control signal representing said determined treatmentselection, if (A) said III is substantially similar to said SII and (B)said first processor determines said input match; whereby said controlinformation inputted via said keypad generates said at least oneexternal treatment device control signal if both said ID match and saidinput match are determined.
 12. The apparatus defined in claim 11,wherein said first processor is further operative to: (a) determine animage-based treatment selection based on analysis of said compositeimage; and (b) determine said input match if said treatment selectioninputted to said keypad is identical to said image-based treatmentselection.
 13. The apparatus defined in claim 6, wherein: (a) each ofsaid control information and said III are inputted by a camera andtransmitted to said first T/R device, said camera being configured togenerate at least one composite image which includes an act of saidhuman medical expert inputting said control information, said imageincluding each of: (1) a body part of said human in the act of selectinga treatment choice from among a plurality of treatment choices, (2) aunique identifying feature of said human, and (3) each visiblecontiguous body part lying between said selecting body part (1) and saididentifying body part (2); (b) said first processor is further operativeto determine an absence of at least one of said contiguous body parts insaid composite image; and (c) upon determination of said absence, saidfirst processor is further operative to prevent the determination ofsaid ID match.
 14. The apparatus defined in claim 1, further comprisinga control device, said control device comprising: (a) a controltransmitting device for transmitting signals to said first T/R device;(b) at least one input device for inputting (i) said controlinformation, and (ii) said incoming identification information; and (c)a second processor, coupled to said control transmitting device and tosaid at least one input device for causing said control transmittingdevice to transmit said control information and said incomingidentification information to said first T/R device; wherein said inputdevice is configured to input identification information of a humanmedical expert who inputs said control information.
 15. The apparatusdefined in claim 14, wherein one input device is operative to input bothsaid control information and said incoming identification information.16. The apparatus defined in claim 14, comprising at least one inputdevice for inputting said control information and at least one otherinput device for inputting said identification information.
 17. Theapparatus defined in claim 16, wherein said device for inputting controlinformation is a keypad, and said device for inputting identificationinformation is a camera.
 18. The apparatus defined in claim 14, whereinsaid control device further comprises: (d) a control receiving device,coupled to said second processor, for receiving a notification signalfrom said first T/R device, and (e) a presentation device, coupled tosaid second processor, for presenting the information represented bysaid notification signal to said medical expert; wherein said processoris further operative to cause said presentation device to display saidinformation to said medical expert.
 19. The apparatus define in claim18, wherein said presentation device presents visual information. 20.The apparatus defined in claim 18, wherein said presentation devicepresents audio information.
 21. The apparatus defined in claim 14,wherein at least one input device is a camera configured to generate atleast one image representing identification information of a humanmedical expert providing said control information.
 22. The apparatusdefined in claim 21, wherein said camera is configured to image afingerprint of a finger of said human medical expert.
 23. The apparatusdefined in claim 22, wherein said camera is further configured to imagesaid finger inputting said control information which is the source ofsaid fingerprint.
 24. The apparatus defined in claim 23, furthercomprising a keypad, imaged by said camera, for indicating said inputtedcontrol information by said finger.
 25. The apparatus defined in claim24, wherein: (a) said keypad is at least partially transparent; (b) saidcamera is situated on a side of said keypad opposite said finger, forimaging the act of said keypad selection including both (i) saidfingerprint and (ii) said finger indicating said keypad selection; and(c) said control information represents said keypad selection.
 26. Theapparatus defined in claim 24, wherein said keypad is further operativeto generate a signal indicating said control information.
 27. Theapparatus defined in claim 24, wherein said keypad comprises atouch-sensitive screen.
 28. The apparatus defined in claim 24, whereinsaid keypad is a virtual keypad.
 29. The apparatus defined in claim 24,wherein said keypad is a mechanical keypad.
 30. The apparatus defined inclaim 21, wherein said camera is configured to image an iris of an eyeof said human medical expert.
 31. The apparatus defined in claim 21,wherein said camera is configured to image a retina of an eye of saidhuman medical expert.
 32. The apparatus defined in claim 21, whereinsaid camera is configured to image a face of said human medical expert.33. The apparatus defined in claim 21, wherein said camera is orientedsuch that each image includes each of: (a) a body part causing the inputof said control information; (b) a body part displaying saididentification information; and (c) each of the contiguous body partslying between said inputting body part (a) and said identifying bodypart (b).
 34. The apparatus defined in claim 14, wherein at least oneinput device is a microphone for inputting audio information.
 35. Theapparatus defined in claim 14, wherein at least one input device is akeypad, for inputting alphanumeric information.
 36. The apparatusdefined in claim 1, further comprising an automatic control device, saidautomatic control device comprising: (a) an automatic control T/R devicefor communication with said first T/R device; (b) a third processor,coupled to said automatic control T/R device for (A) generating said atleast one external signal representing (i) said control information forthe IMD, and (ii) said incoming identification information whichidentifies said automatic control device, in response to said medicaldata received by said automatic control T/R device from said first T/R;and (B) causing said automatic control T/R device to transmit said atleast one external signal to said first T/R.
 37. The apparatus definedin claim 1, wherein upon said determination that said III and said SIIare substantially similar, said first processor is further operative (i)to generate a confirmation signal and (ii) to cause said first T/Rdevice to transmit said confirmation signal.
 38. The apparatus definedin claim 1, wherein upon a determination by said first processor thatsaid III and said SIT are not substantially similar: (a) said firstprocessor does not generate said at least one external treatment devicecontrol signal in response to said at least one external signal receivedfrom the external location by said first T/R device; and (b) said firstprocessor is operative (i) to generate a non-confirmation signal and(ii) to cause said first T/R device to transmit said non-confirmationsignal.
 39. The apparatus defined in claim 21, further comprising: (d) aprompt receiving device, coupled to said second processor, for receivinga prompt signal from said first T/R device, and (e) a prompt producingdevice, coupled to said second processor, for producing at least oneprompt in response to said prompt signal, said prompt inducing at leastone change in the appearance of a visible identifying feature of a humanmedical expert who wishes to control said IMD; wherein: (i) said SIIincludes a plurality of images of at least one visible identifyingfeature of at least one registered human medical expert (“RHME”) who isallowed to control said IMD; (ii) said first processor is furtheroperative to produce at least one prompt signal for transmission to saidprompt producing device; (iii) said camera is operative to repeatedlygenerate images of said visible identifying feature of said humanmedical expert; (iv) said first processor is further operative to: (A)compare each of said repeated images of said identifying feature of saidhuman medical expert with said SII to verify the identity of the humanmedical expert; and (B) indicate said ID match only if both: (1) the IIIis substantially similar to said SII prior to the transmission of saidprompt signal, and (2) the III is substantially similar to said SIIafter the transmission of said prompt signal; thereby to verify that thehuman medical expert is the same individual as one of said at least oneRHME, or to determine that the human medical expert is not the sameindividual as any one of said at least one RHME.
 40. The apparatusdefined in claim 39, wherein (i) said prompt producing device is a lightsource, located in proximity to said human medical expert and arrangedto provide light which impinges on a visible feature of said humanmedical expert; and (ii) said prompt is an instruction which causes saidprompt producing device to alter the light output of said device. 41.The apparatus defined in claim 40, wherein (i) said SII comprises aplurality of images of an iris of a RHME, obtained during each of aplurality of lighting conditions; (ii) said prompt producing device isarranged to provide light which impinges on an eye of said human medicalexpert, for altering the anatomic configuration of a respective iris ofsaid eye; (iii) said control transmitting device is operative totransmit at least one of said images of said iris to said IMD before andafter the transmission of said prompt; (iv) said first processor isoperative to compare the received iris images before the transmission ofsaid prompt with said SII; (v) said first processor is further operativeto compare the received iris images after the transmission of saidprompt with said SII; and (vi) said first processor is operative toindicate said ID match if both said comparisons indicate an ID match.42. The apparatus defined in claim 40, wherein (i) said SII comprises aplurality of images of a visible anatomic feature of a RHME, obtainedduring each of a plurality of lighting conditions; (ii) said promptproducing device is arranged to provide light which impinges on saidanatomic feature of said human medical expert, for altering a lightingcondition which determines the appearance of said anatomic feature;(iii) said control transmitting device is operative to transmit at leastone of said images of said anatomic feature to said IMD before and afterthe transmission of said prompt; (iv) said first processor is operativeto compare the received images before the transmission of said promptwith said SII; (v) said first processor is further operative to comparethe received images after the transmission of said prompt with said SII;and (vi) said first processor is operative to indicate said ID match ifboth said comparisons indicate an ID match.
 43. The apparatus defined inclaim 39, wherein (i) said SII comprises a plurality of images of avisible anatomic feature, whose appearance is subject to voluntaryalteration by said human medical expert; (ii) said prompt producingdevice is arranged to provide an instruction to said human medicalexpert to execute said alteration; (iii) said control transmittingdevice is operative to transmit at least one of said images of saidanatomic feature to said IMD before and after the transmission of saidprompt; (iv) said first processor is operative to compare the receivedimages before the transmission of said prompt with said SII; (v) saidfirst processor is further operative to compare the received imagesafter the transmission of said prompt with said SIT; and (vi) said firstprocessor is operative to indicate said ID match if both saidcomparisons indicate an ID match.
 44. The apparatus defined in claim 39,wherein said prompt producing device is configured to provide aninstruction requiring said human medical expert to speak.
 45. Theapparatus defined in claim 39, wherein said prompt producing device isconfigured to provide a painful stimulus to said human medical expert.46. A method of controlling an electronic medical apparatus adapted tobe implanted in a human patient, a so-called implantable medical device(IMD), which may treat a medical condition in a patient following thedetection by said device of an abnormality, which may be alternatively(A) automatically self-controlled by said IMD and (B) externallycontrolled by a properly identified medical expert, said methodcomprising the steps of: (1) at said IMD, storing identificationinformation pertaining to a medical expert permitted to control an IMDimplanted in a patient; (2) at said IMD, monitoring signals whichcontain information about at least one medical state in said patient andproducing medical condition signals representative of said state; (3) atsaid IMD, detecting a medical abnormality which may require treatment,based on said signals; (4) upon detection of said medical abnormality,determining at said IMD whether said treatment is to be selected (A)automatically by said IMD or (B) by said medical expert; (5) if saiddetermination is for said IMD-selected automatic treatment,automatically selecting and administering said treatment at said IMD, iftreatment is warranted; (6) if said determination is for selection oftreatment by said medical expert; (a) transmitting information from saidIMD concerning said medical abnormality to said medical expert; (b)receiving said information for review by said medical expert; (c) saidmedical expert selecting the treatment of said medical abnormality, iftreatment is warranted; (d) said medical expert transmitting to said IMD(i) at least one treatment control signal, and (ii) informationidentifying said medical expert, if treatment is warranted; and (e) atsaid IMD, receiving said at least one treatment control signal and saidincoming identification information (“III”); (f) at said IMD, comparingsaid III with said stored identification information (“SII”); (g) atsaid IMD, administering said medical expert-selected treatment, inresponse to said at least one treatment control signal, if saidcomparison indicates that said III is substantially similar to said SII.47. A method of controlling an electronic medical apparatus adapted tobe implanted in a human patient, a so-called implantable medical device(IMD), which may treat a medical condition in a patient following thedetection by said device of an abnormality, which may be alternatively(A) automatically self-controlled by said IMD and (B) controlled by amedical expert, said method comprising the steps of: (1) at said IMD,storing identification information pertaining to a medical expertpermitted to control said IMD; (2) at said IMD, monitoring informationabout at least one medical state in a patient and producing at least onemedical condition signal representative of said medical state; (3) atsaid IMD, detecting a first apparent medical abnormality which mayrequire treatment, based on said at least one medical condition signal;(4) at said IMD, upon detection of said first apparent medicalabnormality, transmitting said at least one medical condition signal toa medical expert; (5) at said IMD, detecting a second apparent medicalabnormality which may require treatment, based on said at least onemedical condition signal, and, upon detection of said second apparentmedical abnormality generating a local treatment control signal; (6) atsaid IMD, in the absence of a received external treatment controlsignal, administering a first treatment to said patient specified bysaid local treatment control signal, if any; (7) said medical expertreceiving said at least one medical condition signal and making adetermination of whether treatment is warranted based on said at leastone received medical condition signal and, if said treatment iswarranted, transmitting at least one external treatment control signalto said IMD, said at least one external treatment control signalrepresenting (A) a second treatment to be administered by said IMD and(B) identification information of said medical expert; (8) at said IMD,receiving said at least one external treatment control signal andcomparing said incoming identification information with said storedidentification information; and (9) at said IMD, if said secondtreatment is different from said first treatment, and if said comparisonindicates that said incoming identification information is substantiallysimilar to said stored identification information, administering saidsecond treatment to said patient.